Identity
- Device Name
- Disposable medical mask EUDAMED
- Model / Reference
- MDN11214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975117810108 EUDAMED
- Basic UDI-DI
- 697511781XRFM10132 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable medical mask by Xiantao Xingrong Protective Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697511781XRFM10132 | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Xingrong Protective Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000020687
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED f39228ad-bf11-4ac1-82cd-7fbe826afe7b 61 fields · synced Jun 19, 2026